Class 2 Device Recall H. pylori (polyclonal)

• Date Initiated by Firm: May 05, 2017
• Date Posted: June 01, 2017
• Recall Status: Terminated on September 07, 2017
• Recall Number: Z-2202-2017
• Recall Event ID: 77209
• Product Classification: Immunohistochemical assay, Helicobacter pylori - Product Code OWF
• Product: H. pylori (polyclonal}; 1.0 mL Catalog number 215A-76;; ; Hematology - Analyte Specific Reagent; In vitro diagnostic use - Analyte Specific Reagent
• Code Information: 1.0 ml lot 1611307C, expiry 201 9-03.
• Recalling Firm/ Manufacturer: Cell Marque Corporation; 6600 Sierra College Blvd; Rocklin CA 95677-4306
• For Additional Information Contact: Veronica Runyan; 916-746-8977
• Manufacturer Reason for Recall: Cell Marque has determined the need to issue a product recall after identifying product intended to be sold outside the U.S. was not properly labeled as "For Export Only" as required by section 801 (e )(1) of the FD&C Act.
• FDA Determined Cause: Labeling mix-ups
• Action: Cell Marque sent notification letters by e-mail directly to domestic customers who were shipping affected products on May 9, 2017. Letters asked that unused product be destroyed and that amount destroyed and amount already used be recorded on the acknowledgment form and returned per instructions. UPDATE: Firm called DO on May 24, 2017 to inform us that the recall letters did not go out as expected on May 9, 2917 due to employee not performing assigned task. Director of Quality made sure letters went out on May 24th by e-mail and has already received some responses. She will also follow op with personal phone calls. Customers with questions were instructed to contact their Customer Care team at 800-665-7284 or 916-746-8900 or email sevrice@cellmarque.com. For questions regarding this recall call 916-746-8977.
• Quantity in Commerce: 5
• Distribution: Nationwide Distribution to CA, CO, DE, FL, GA, IL, KY, MD, MA, MS, NJ, NY, NC, OH, OK, OR, PA, TX.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.